A Multipart, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with sHLH.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:
• ≥12 years at the time of HLH diagnosis (Cohort 1).
• Treatment naïve or relapsed/refractory (Cohorts 1 and 2).
• Treatment naïve or early refractory (Cohort 3).
• Participant with sHLH confirmed criteria based on fulfilling 5 out of 8 HLH-2004 diagnostic criteria.
• Cohort A: Adults with treatment-naïve, malignancy-associated sHLH.
• Cohort B: Adults with treatment-naïve, non-malignancy-associated sHLH.
• Cohort B: Adults with treatment-naïve, malignancy-associated sHLH, diagnosed by OHI index.
• Cohort B: 13 to 17 years olds with treatment-naïve sHLH.
• Cohort B: 6 to 12 year olds, with refractory sHLH (safety lead-in cohort).
• Cohort B: 6 to 12 year olds, with treatment-naïve sHLH (after completion of safety lead-in cohort).
Locations
United States
Alabama
University of Alabama at Birmingham School of Medicine
RECRUITING
Birmingham
Arizona
Phoenix Children's Hospital
ACTIVE_NOT_RECRUITING
Phoenix
California
University of California, Los Angeles
ACTIVE_NOT_RECRUITING
Los Angeles
Washington, D.c.
MedStar Georgetown
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Johns Hopkins All Children's Hospital
RECRUITING
St. Petersburg
New York
Columbia University
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Texas
Texas Children's Hospital
RECRUITING
Houston
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Other Locations
Austria
Medizinische Universität Innsbruck
WITHDRAWN
Innsbruck
Medical University of Vienna
COMPLETED
Vienna
Germany
Universitätsklinikum Jena
RECRUITING
Jena
Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
COMPLETED
Milan
Bambino Gesu' Roma
WITHDRAWN
Roma
Netherlands
Amsterdam UMC
ACTIVE_NOT_RECRUITING
Amsterdam
Erasmus UMC
ACTIVE_NOT_RECRUITING
Rotterdam
Spain
Hospital 12 de Octubre, Madrid
WITHDRAWN
Madrid
Hospital Ramon y Cajal
COMPLETED
Madrid
Hospital La Fe Valencia
WITHDRAWN
Valencia
United Kingdom
University College London Hospitals
ACTIVE_NOT_RECRUITING
London
Contact Information
Primary
Clinical Trials
clinicaltrials@electra-therapeutics.com
Please email
Time Frame
Start Date:2022-05-19
Estimated Completion Date:2029-06
Participants
Target number of participants:156
Treatments
Experimental: Part 1 ELA026
Cohort 1: Single dose escalation up to 3.0 mg/kg IV or SC.~Cohort 2: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Day 2 - 4, followed by weekly maintenance doses of 1 mg/kg IV/SC from Day 8 to Day 81.~Cohort 3: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg IV/SC from Day 8 to Day 81.
Experimental: Part 2 ELA026
Cohort A and Cohort B: priming dose: 0.1 mg/kg IV on Day 1; loading dose 0.3 mg/kg IV on Days 2- 4, followed by twice weekly maintenance doses of 0.5 mg/kg (IV/SC) from Day 8 to Day 81.